Takeda Announces U.S. FDA Approval of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content1

GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with Less Than or Equal to 2 g/mL IgA in a 10% Solution is Approved for Intravenous or Subcutaneous Use in People Aged Two and Older with Primary Immunodeficiency1
U.S. Commercialization of GAMMAGARD LIQUID ERC Projected to Begin in 2026
Company Announces Future Manufacturing Discontinuation End Date for Takeda's First-Generation Low-IgA Product, A Freeze-Dried Formulation in Company’s Differentiated Immunoglobulin Portfolio of Ready-to-Use Liquids2

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with less than or equal to 2 µg/mL IgA in a 10% solution, the only ready-to-use liquid immunoglobulin (IG) therapy with low immunoglobulin A (IgA) content, as replacement therapy for people two years of age and older with primary immunodeficiency (PI). As a ready-to-use liquid, GAMMAGARD LIQUID ERC may help ease the administration burden for patients and their health care providers by eliminating the need for reconstitution and can be administered intravenously or subcutaneously.1

“The approval of GAMMAGARD LIQUID ERC reinforces our commitment to supporting individualized treatment approaches for people with primary immunodeficiency, including a therapeutic option that has the lowest IgA content of any ready-to-use liquid immunoglobulin therapy, and can be administered intravenously or subcutaneously,” said Kristina Allikmets, senior vice president and head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit. “GAMMAGARD LIQUID ERC uses the same state-of-the-art manufacturing process as our other ready-to-use liquid immunoglobulin formulations and is aligned with our forward-looking strategy to prioritize reliable supply while offering a broad range of immunoglobulin therapies to address varied patient needs.”

With this approval, Takeda continues to be the only manufacturer of IG therapy with low IgA content less than or equal to 2 µg/mL in a 10% solution.1 It is anticipated that commercialization of GAMMAGARD LIQUID ERC will begin in the U.S. in 2026, followed by the European Union in 2027, where GAMMAGARD LIQUID ERC is approved by the European Medicines Agency (EMA) as DEQSIGA®.3 The timeline to commercial launch is consistent with the time it takes to ramp up manufacturing and supply for plasma-derived therapies.

In parallel to this approval, and after thorough analysis, Takeda has decided to discontinue GAMMAGARD S/D [Immune Globulin Intravenous (Human)] IgA less than 1 µg/mL in a 5% solution, the company’s first-generation low IgA product.2 As the only lyophilized (freeze-dried) preparation in Takeda’s IG portfolio, GAMMAGARD S/D uses a different, older manufacturing process. For GAMMAGARD S/D, this process is no longer able to reliably meet the future needs of the patient community. Therefore, Takeda has informed the FDA and other health authorities that manufacturing of GAMMAGARD S/D will be discontinued at the end of December 2027. Beyond that date, Takeda intends to maintain GAMMAGARD S/D inventory until it is depleted or expired.

“We understand the impact that this news may have on patients who currently rely on GAMMAGARD S/D for their treatment,” said Kristina Allikmets. “We are communicating this information now to allow time for patients to work closely with their health care teams to develop alternative treatment plans.”

About GAMMAGARD LIQUID ERC
GAMMAGARD LIQUID ERC is a ready-to-use liquid immunoglobulin therapy with an IgA content of less than or equal to 2 µg/mL in a 10% solution to be administered intravenously or subcutaneously. It is indicated in the United States as replacement therapy for primary immunodeficiency (PI) in people two years of age and older.1

GAMMAGARD LIQUID ERC shares its manufacturing process with GAMMAGARD LIQUID [Immune Globulin Infusion (Human)], with the modification of parameters in a single process step to improve IgA reduction. This enhanced removal capability (ERC) results in a product with IgA less than or equal to 2 µg/mL in a 10% solution.1

While GAMMAGARD LIQUID ERC is not indicated specifically for IgA sensitivity in people with primary immunodeficiency, it may be an appropriate option for them based on their physician’s clinical judgment. GAMMAGARD LIQUID ERC is contraindicated in patients with a history of severe systemic hypersensitivity or anaphylactic reactions to the product. It also carries warnings and precautions regarding the potential for severe hypersensitivity reactions, including in patients who have previously tolerated immune globulin products. Despite containing low levels of IgA (≤2 µg/mL in a 10% solution), the risk of anaphylaxis remains.1

About GAMMAGARD S/D
GAMMAGARD S/D is lyophilized (freeze-dried) immunoglobulin therapy with IgA content less than 1 µg/mL in a 5% solution for intravenous use only. It is indicated for the treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years and older. GAMMAGARD S/D is also indicated for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell CLL, for the treatment of adult patients with chronic immune thrombocytopenic purpura (ITP) to increase platelet count and to prevent and/or to control bleeding, and for the prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients.2

About Primary Immunodeficiency (PI)
Primary immunodeficiency (PI) is a group of more than 550 rare and chronic disorders, where a part of the body’s immune system is missing or does not function the way it should.4 These conditions result from genetic mutations, which are usually inherited.5 The symptoms of PI vary and can include frequent and/or persistent infections and unusual autoimmunity, often leading to prolonged periods of misdiagnosis despite consultations with multiple specialists.6 In the United States, PI affects about 1 in 1,200 people.7

GAMMAGARD LIQUID ERC, GAMMAGARD LIQUID and GAMMAGARD S/D U.S. Important Safety Information

WARNING: THROMBOSIS Thrombosis may occur with immune globulin (IG) products, including GAMMAGARD LIQUID, GAMMAGARD LIQUID ERC and GAMMAGARD S/D. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk fators. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer GAMMAGARD LIQUID, GAMMAGARD LIQUID ERC and GAMMAGARD S/D at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity. WARNING: RENAL DYSFUNCTION and ACUTE RENAL FAILURE Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products, including GAMMAGARD LIQUID, GAMMAGARD LIQUID ERC and GAMMAGARD S/D. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAGARD LIQUID, GAMMAGARD LIQUID ERC and GAMMAGARD S/D do not contain sucrose.